Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application
Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application
Niagara Falls, NY , Feb. 17, 2022 (GLOBE NEWSWIRE) -- Positron Corporation ("Positron" or the "Company") (OTC: POSC), a nuclear medicine PET imaging device systems and clinical services company, is pleased to announce today that the Company has retained Medical Device Academy "MDA") as its consultant for the Company's new PET/CT device 510K submission with the Food and Drug Administration ("FDA").
紐約州尼亞加拉瀑布，2022年2月17日(環球網)--核醫學PET成像設備系統和臨牀服務公司Positron Corporation(以下簡稱“Positron”或“公司”)(場外交易代碼：POSC)今天高興地宣佈，該公司已聘請美國醫療器械學會(以下簡稱“MDA”)作為其顧問，負責向食品和藥物管理局(FDA)提交新的PET/CT設備510K。
Positron will be applying for new device approval to market and sell its PET/CT device in the United States. The Company plans to file its 510K application within 60 days and anticipates it will receive approval within 100 days from initial filing date.
正電子將申請新設備的批准，以便在美國市場上銷售其PET/CT設備。該公司計劃在60天內提交其510K申請，預計將在最初提交日期起100天內獲得批准。
Adel Abdullah, President of Positron stated: "The seasoned team at MDA come highly recommended for their expertise, analysis and assessment of the processes required for our new application to be successfully cleared by the FDA. During the past several months we have been preparing our database to accept & present all relevant information and documentation for our 510K application. Hiring a skilled specialist such as MDA is key and the next step for Positron's business to offer a state-of-the-art PET/CT device delivering the best images for cardiac patients and our future expected oncology customers."
正電子公司總裁阿德爾·阿卜杜拉(Adel Abdullah)表示：“MDA經驗豐富的團隊因其專業知識、對我們的新申請成功獲得FDA批准所需流程的分析和評估而受到強烈推薦。在過去的幾個月裏，我們一直在準備我們的數據庫，以接受和呈現我們510K申請的所有相關信息和文件。聘請像MDA這樣熟練的專家是關鍵，也是正電子公司業務提供最先進的PET/CT設備的下一步，該設備將為心臟病患者和我們預期的未來腫瘤提供最好的圖像。
About Positron Corporation
關於正電子公司
About Positron: Positron Corporation is a nuclear medicine PET imaging device company specializing in the field of cardiac Positron Emission Tomography imaging - the gold standard in cardiac diagnostics. Positron's innovative PET technology, clinical services and practice solutions enables healthcare providers to more accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron's PET only system, market position and approach in facilitating the adoption of cardiac PET are substantial advantages to the growth of the market and Positron. Positron will soon offer a state-of-the-art PET/CT imaging device that will enable nuclear cardiologists to utilize the full power of nuclear imaging. This same PET/CT device allows Positron to address and meet the needs and demand of the vast oncology diagnostics marketplace.
關於正電子：正電子公司是一家核醫學PET成像設備公司，專門從事心臟正電子發射斷層掃描成像領域-心臟診斷的黃金標準。正電子的創新PET技術、臨牀服務和實踐解決方案使醫療保健提供者能夠更準確地診斷冠狀動脈疾病並改善患者預後，同時實踐具有成本效益的藥物。正電子唯一的PET系統、在促進心臟PET採用方面的市場地位和方法對市場和正電子的增長具有實質性的優勢。正電子將很快提供一種最先進的PET/CT成像設備，使核心髒病學家能夠充分利用核成像的能力。同樣的PET/CT設備使正電子能夠滿足和滿足龐大的腫瘤學診斷市場的需要和需求。
Forward-Looking Statements
前瞻性陳述
This press release contains statements, which may constitute "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.
本新聞稿包含經1995年私人證券訴訟改革法修訂的1933年“證券法”和1934年“證券交易法”所指的“前瞻性陳述”。這些陳述包括關於正電子公司及其管理層成員的意圖、信念或當前預期的陳述，以及這些陳述所基於的假設。敬請潛在投資者注意，任何此類前瞻性陳述都不能保證未來的業績，涉及風險和不確定因素，實際結果可能與此類前瞻性陳述中預期的大不相同。公司沒有義務更新或修改前瞻性陳述，以反映假設的變化、意外事件的發生或未來經營業績的變化。
FOR FURTHER INFORMATION, please visit the company's website at , or contact:
Investor Relations Contact:
Skyline Corporate Communications Group, LLC
Lisa Gray, Senior Account Manager
One Rockefeller Plaza, 11th Floor
New York, NY 10020
Office: (646) 893-5835
Email: lisa@skylineccg.com
欲瞭解更多信息，請訪問公司網站，或聯繫：
投資者關係聯繫人：
天際通信集團有限責任公司
高級客户經理麗莎·格雷
洛克菲勒廣場一號，11樓
紐約州紐約市，郵編：10020
辦公室：(646)893-5835
電子郵件：lisa@sky lineccg.com
譯文內容由第三人軟體翻譯。